A Study of E6005 in Japanese Patients With Atopic Dermatitis
This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: August 4, 2010
Last updated: January 31, 2014
Last verified: January 2014
The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis
Primary Outcome Measures:
- Pharmacokinetic parameter Cmax will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter tmax will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter AUC(0-t) will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
- Pharmacokinetic parameter t1/2 will be calculated [ Time Frame: Until Day 13 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005.
Placebo Comparator: 2
Matching placebo for each step
|Ages Eligible for Study:
||20 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
- Patients with evaluable typical eczema on the back (posterior trunk).
- Patients whose age is equal to or more than 20 and less than 65 at the time of treatment and who can provide written informed consent.
- Patients complicated with eye symptoms (e.g., cataract, retinal detachment), Kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa.
- Patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to E6005 or any of their excipients.
- Patients who received any concomitant ethical drugs or any phototherapies within 14 days prior to Baseline. Subjects are allowed to use external steroids and tacrolimus ointment 8 or more days before Baseline and bland emollients free of medicinal properties (e.g., white petrolatum) throughout the study period.
- Patients with any infection that required hospitalization or intravenous/oral treatment with antibiotic/antiviral/antifungal drug(s) within 28 days prior to Baseline.
- Patients who had or have any malignancy, lymphoma, leukemia, or lymphoproliferative disorders, which dose not include skin cancers (e.g., squamous cell carcinoma or basal cell cancer) that were completely removed and have not metastasized for 5 years.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01179880
Eisai Co., Ltd.
||Frontier Product Creation Unit, Eisai Product Creation Systems
No publications provided
||Eisai Inc. ( Eisai Co., Ltd. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 4, 2010
||January 31, 2014
||Japan: Ministry of Health, Labor and Welfare
Keywords provided by Eisai Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014
Genetic Diseases, Inborn
Immune System Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic